The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has started the second rolling review for a vaccine against COVID-19 for Europe. The purpose of the procedure is to accelerate the assessment process with the aim of obtaining COVID-19 vaccine approval by starting the assessment of data packages for the non-clinical and clinical development of a vaccine candidate before all the data required for an application for approval have been collected and submitted. The rolling review process will continue until the data provide sufficient evidence to enable a formal application for approval and a risk-benefit assessment. Despite the acceleration, the requirements for quality, safety and efficacy of the drugs in question remain high. The vaccine is a COVID-19 vaccine candidate from Biotech.
The evaluation of a whole range of pharmaceuticals in Europe is coordinated in a centralized process by the European Medicines Agency (EMA), while approval for all EU member states is carried out by the European Commission. The evaluation of an application for approval after the application has been submitted by the experts from the national pharmaceutical authorities takes up to 210 working days. Added to this is the time required by the applicant to answer questions and, if necessary, to compile further data. The entire evaluation process usually takes significantly longer than a year. The regular expedited assessment process allows 170 days for regulatory assessment. Further reductions are possible in the event of an emergency such as a health threat to the population. Now, with a second COVID-19 vaccine candidate, the rolling review process - the continuous review of successively submitted data packages - is used in order to further shorten the assessment time as far as possible.
Normally, a complete application for approval with all the necessary data must be submitted before the assessment process begins. In the rolling review process, on the other hand, the lead reviewers (rapporteur and co-rapporteur, experts from two EU member states) of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) already evaluate individual successive data packages as soon as they are available and have been submitted . At the end of this rolling review, the CHMP will also check at what point in time sufficient data are available to allow a conclusive risk-benefit assessment. A decision by the CHMP on the recommendation to approve a vaccine candidate to the European Commission is then made comparatively quickly.
The CHMP's decision to begin the ongoing review of Biotech's COVID-19 vaccine is based on preliminary results from non-clinical studies as well as early adult clinical trials suggesting that the vaccine product is immunologic in humans, i.e. can trigger specific immune reactions against SARS coronavirus-2. A rolling review and expedited assessment process does not mean that there will be a trade-off in terms of due diligence.
The Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Medicines, supports COVID-19 vaccine development with the highest priority. Experts from the Paul Ehrlich Institute are actively involved in European centralized approval procedures and drug evaluations, and often play a leading role.
The COVID-19 vaccine product BNT162b2 developed by Biotech is a so-called mRNA vaccine. The messenger RNA (mRNA) of the vaccine BNT162b2 contains genetic information for the blueprint of the spike protein of the SARS coronavirus-2 and is mixed with small fat molecules (lipid particles) that mediate the uptake of the mRNA in a few human cells. After vaccination, the genetic information is read from the receiving cells in the body and the spike protein is produced and presented to the immune system. The immune system recognizes the spike protein as foreign and forms, among other things, Antibodies and T cells designed to protect against symptomatic infection or severe COVID-19 disease.
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